Kornimate/medical-research-clean huggingface dataset:
study of surgical practices in patients with haemophilia a or b treated with an extended half-life recombinant factor viii-fc or ix-fc (elocta®, alprolix®)

Conditions: Hemophilia A; Hemophilia B

Summary: haemophilia a and haemophilia b are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors viii and ix, respectively. the peri-operative period of people with haemophilia is commonly managed with replacement therapy. in phase 3 studies of elocta® (extended half-life recombinant factor viii-fc) and alprolix® (extended half-life recombinant factor ix-fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating fviii and fix levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. in 2019, the national protocol for diagnosis and care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor viii/ix or a continuous infusion of fviii/ix. many countries, including france, have adopted these rfviii/ixfc therapeuitic products and recommended their use in the surgical management of patients. however, the use of these two products in real life during surgery in haemophilic a and b patients has not been described in detail. it seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.


Eligibility criteria:
inclusion criteria: * patient with haemophilia a or b * surgery performed with elocta® or alprolix® * information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors exclusion criteria: * any blood coagulation disorder other than haemophilia a or b * patient with factor viii or ix inhibitor * severe liver disease (serum alat/asat levels\> 5 x uln) * severe renal disease (serum creatinine \> 2x uln) * known hypersensitivity to the substances or its excipients * patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)

Keywords: surgery haemophilia a haemophilia b elocta® alprolix®
what is the best preparation for embryo transfer in cryo cycles: a natural cycle or light hormonal stimulation?

Conditions: Infertility

Summary: the study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.


Eligibility criteria:
inclusion criteria: * signed informed consent. * women with a regular cycle (between 21 and 35 days). * embryos with 50% intact blastomeres after thawing. * embryo and endometrium are synchronized. exclusion criteria: * embryo storage time not longer than 5 years.

Keywords: subfertility endometrium thickness implantation rate embryo cryopreservation embryo transfer
periinterventional outcome study in the elderly

Conditions: Mortality; Complication, Postoperative

Summary: the pose study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in europe.

elderly population (≥80 years) will increase from 5.3% of the total population in 2015 to 9% in 2040. this implies an increasing number and variety of surgical and non-surgical interventional procedures. little is known about the in-hospital mortality rates in the overall elderly interventional population. compared with younger interventional patients, the elderly are at greater risk of peri-interventional mortality and morbidity, because of decline in physiological and cognitive reserve, and frequent comorbidities. previous data are mostly limited to specific populations, like the elderly hip fracture patient. the investigators aim to recruit as many as possible centers throughout europe, to participate in this study. a total sample size of 7500 patients will provide reasonable and valid results for the study aims. the primary endpoint will be analysed by fitting a cox-regression model to the data of the post-interventional mortality until day 30.

Eligibility criteria:
inclusion criteria: * age ≥ 80 years * written informed consent according to the national law requirements * all consecutive patients undergoing surgical and non-surgical interventions (e.g. radiological, neuroradiological, cardiological, gastroenterological) with anaesthesia care (done by an anaesthetist) within the selected inclusion period of four weeks * elective and emergency procedures * in-patient and out-patient procedures exclusion criteria: * people who are institutionalized by court or administrative order * patients with re-intervention within the 4 week period, who were already enrolled in this study

Keywords: elderly patients, mortality, morbidity, post-intervention
acupuncture for individuals with stable angina

Conditions: Angina, Stable; Chest Pain; Microvascular Angina; Heart Failure

Summary: this rct aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms, chest pain, and/or chest discomfort. the investigators want to determine if acupuncture reduces the pain and other symptoms of angina, chest pain, and chest discomfort. the investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women.

the investigators are conducting a rct aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (rct) to test the effect of acupuncture on anginal symptoms, chest pain, and chest discomfort in men and women. the investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina, chest pain, and chest discomfort. this study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, chest pain which includes non-ischemic or ischemic cardiomyopathy, microvascular coronary dysfunction (mcd), heart failure with preserved ejection fraction (hfpef), heart failure with reduced ejection fraction (hfref), or chest discomfort whose pain and associated symptoms have not been completely controlled with guideline-directed medical management. the investigators will use a randomized attention control design with 13 men and women assigned to initial acupuncture and 13 to control. participants in the experimental group will receive a standardized acupuncture point prescription two treatments per week, for 5 weeks. the attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.

Eligibility criteria:
inclusion criteria: * provision of a verified diagnosis from a care provider * male or female sex * at least 21 years of age * intermittent angina symptoms (pain, pressure, or discomfort in the chest or other areas of the upper body) * medical confirmation of a diagnosis of stable angina for at least 6 months medical confirmation of a diagnosis of chest pain including non-ischemic or ischemic cardiomyopathy medical confirmation of a diagnosis of microvascular coronary dysfunction (mcd) medical confirmation of a diagnosis of heart failure with preserved ejection fraction (hfpef), heart failure with reduced ejection fraction (hfref) medical confirmation of chest discomfort. exclusion criteria: * pregnancy * chronic obstructive pulmonary disease (copd) causing pain or associated symptoms * autoimmune dysfunction * use of steroid medications * concomitant physical therapy * biofeedback * massage * additional acupuncture
innovative pulmonary solutions (ips) system for targeted lung denervation

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to evaluate the safety of targeted lung denervation therapy (or tld therapytm) in patients suffering from copd. technical feasibility of the ips systemtm will also be evaluated through confirmation of successful application of tld therapy.


Eligibility criteria:
inclusion criteria: * fev1 30% to 60% * fev1/fvc \<70% * prior smoker (at least 10 pack years) * quit smoking for at least 6 months exclusion criteria: * pulmonary hypertension, peripheral edema suggesting chf or polycythemia * prior lung transplant, lvr, lvrs, median sternotomy, bullectomy or lobectomy * pulmonary nodule requiring surgery * presence of implantable electronic devices * active respiratory infection within recent weeks * copd exacerbation within recent weeks * recent myocardial infarction (mi) * recent and unstable or life threatening arrhythmia * malignancy treated with radiation or chemotherapy within the last 2 years * presence or clinical diagnosis of other respiratory diseases other than copd

Keywords: chronic obstructive pulmonary disease pulmonary intervention device denervation lung holaira, inc. innovative pulmonary solutions, inc.
investigating musculoskeletal health and wellbeing

Conditions: Musculoskeletal Pain, Frailty, Disability

Summary: background the progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. this study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations. methods a prospective cohort of 10000 people aged \> 18 will be recruited from general practice surgeries, secondary care and the general public. data collection waves will be at baseline,and then annual follow-ups for up to five years. data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain mannikin), pain quality (the mcgill pain questionnaire), central pain (the cap-knee scale), fracture risks (a modified version of the frax instrument), frailty (the fried criteria and the frail scale) and disability (the frail scale). discussion participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.


Eligibility criteria:
inclusion criteria: - ability to give informed consent. aged 18 and over frailty score of ≥ 0.12 on the efi have or are at risk of developing musculoskeletal frailty, pain or disability exclusion criteria: - inadequate understanding of verbal explanations or written information in english; special communication needs; receiving dialysis; receiving home oxygen; terminal cancer; unstable angina or heart failure; serious mental illness; dementia.
miravirsen study in null responder to pegylated interferon alpha plus ribavirin subjects with chronic hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. the subjects enrolled in this study are chronically infected with hcv genotype 1 and are null responders to treatment with peg ifnα/rbv therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic hepatitis c * hcv genotype 1 * bmi 18-38 kg/m2 * null responder to pegylated interferon alpha and ribavirin exclusion criteria: * co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * significant liver disease in addition to hepatitis c * decompensated liver disease medical history or current clinical features * histologic evidence of hepatic cirrhosis * concurrent clinically significant medical diagnosis (other than chc) * concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation) * clinically significant illness within 30 days preceding entry into the study * participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication * history of clinically significant allergic drug reactions

Keywords: antisense mir-122 antagonist host factor chronic hepatitis c hepatitis c
precision medicine in the prostate cancer care pathway

Conditions: Prostate Cancer; Genetic Predisposition

Summary: this study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with / at high risk of prostate cancer. the genetic test will analyse men's dna samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. this study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.


Eligibility criteria:
inclusion criteria: affected cohort: 1. affected with prca \< 70 years or 2. affected with metastatic castration resistant prca (mcrpc) at any age or 3. affected with prca and a family history defined as 1. two or more cases in family with one case \< 70 2. three or more cases any age (fdr or sdr) unaffected cohort: aged \>30 and with a family history defined as: 1. fdr diagnosed \< 70 2. 2 or more cases in first or second degree relatives (fdr/sdr) with one case diagnosed \< 70 years 3. 3 or more cases at any age (on same side of family) exclusion criteria: * • who performance status 4
assess burden of disease among kidney transplant recipients with chronic active antibody mediated rejection

Conditions: Antibody-mediated Rejection in Kidney Transplant

Summary: this study investigates the burden of disease among kidney transplant recipients that have developed chronic active antibody mediated rejection (caamr) compared with kidney transplant recipients that have not developed caamr


Eligibility criteria:
inclusion criteria: chronic active amr group: * 18 years and older * recipient of blood group system (abo) compatible solitary kidney transplant between \[1jan2013\] and \[1jan2018\] * chronic active amr diagnosed via kidney biopsy based upon banff criteria. patients who additionally have diagnoses such as tcmr, acute tubular necrosis, recurrence of primary kidney disease are also eligible if not the predominant pathology. * dsa antibodies within prior 6 months of the biopsy which confirmed chronic active amr * minimum of 3 years of follow up data following diagnosis of chronic active amr (unless patient had died) * egfr at time of diagnosis of chronic active amr of \>25ml/min/1.73m2 non-chronic active amr group: * age 18 years or older * recipient of abo compatible solitary kidney transplant between \[1 jan 2013\] and \[1jan2018\] * no documented diagnosis of chronic active amr during the data extraction period. patients with other diagnoses such as tcmr, acute tubular necrosis, recurrence of primary kidney disease are also eligible. patients may or may not have had biopsies. * minimum of 4 years of follow up data since transplant (unless patient has died) * egfr of \>25ml/min/1.73m2 at time of matching exclusion criteria: chronic active amr group: * recipient of a multi-organ transplant * abo-incompatible transplant * patient lost to follow up within the first 3 years post-diagnosis of chronic active amr and whose allograft status (graft failure or patient death) is unknown. non-chronic active amr group: * recipient of a multi-organ transplant * abo-incompatible transplant * patient lost to follow up within the first 4 years of transplant and whose allograft status (graft failure or patient death) is unknown.
pharmacokinetics of delgocitinib 20 mg/g cream in subjects with chronic hand eczema

Conditions: Chronic Hand Eczema

Summary: the purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema. delgocitinib is a cream that suppresses specific processes in the body's response to diseases like che, such as inflammation. everyone in the trial will use delgocitinib cream. the trial will last up to 7 weeks and there will be 6 visits and a phone call. there will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.


Eligibility criteria:
inclusion criteria: * age 18 years or above at screening. * diagnosis of che, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. * disease severity graded as moderate to severe at screening and baseline according to iga-che (i.e. an iga-che score of 3 or 4). * subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (tcs) (at any time within 1 year before the screening visit) or for whom tcs are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks). * subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens. exclusion criteria: * concurrent skin diseases on the hands, e.g. tinea manuum. * active atopic dermatitis (ad) requiring medical treatment in regions other than the hands and feet. * active psoriasis on any part of the body. * hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body. * clinically significant infection (e.g. impetiginised hand eczema) on the hands. * systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed). * use of tanning beds, phototherapy (e.g. ultraviolet b \[uvb\], ultraviolet a1 \[uva1\], psoralen ultraviolet a \[puva\]), or bleach baths on the hands within 28 days prior to baseline. * cutaneously applied treatment with immunomodulators (e.g. phosphodiesterase 4 \[pde-4\] inhibitors, pimecrolimus, tacrolimus) or tcs on the hands within 14 days prior to baseline. * use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline. * cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
long-term exercise maintenance via internet support

Conditions: Obesity; Inactivity

Summary: each year, a significant portion of men and women who engage in physical activities such as walking or running reduce their activity and by doing so place themselves at greater risk of obesity, heart disease, and diabetes. our own prospective epidemiological studies of runners and walkers suggest that during 7.6 years of follow-up over 40% have reduced their mileage by half or more. research suggests that social support, perceived health benefits, resiliency to interruptions in training, and exercise self-efficacy predict successful maintenance. we have found that runners who successfully maintained or increased their running mileage during this follow-up were more likely to have participated in social events such as marathon, half-marathon, or 10km races. the purpose of this study is to build upon our current internet-based survey tools (www.healthsurvey.org) for tracking physical activity and nutrition on full-function activity and diet logs. the existing software allows participants to visualize their accumulated running and walking mileage on a virtual transcontinental route starting in yorktown, virginia and ending in florence, oregon. to the existing software, we will add the ability to: 1) choose named or anonymous running and walking partners with similar goals and abilities to travel with (or race against) along the transcontinental trail, 2) communicate with partners to provide mutual support, 3) compete as part of virtual running and walking teams created by the user, and 4) be recognized for completing each state on an awards page (optional). interest in the site will be maintained by providing regular updates on scientific research on running and walking through our proprietary software. the updates will be created from pubmed abstracts that are made more reader friendly by defining all scientific terms in pop-up balloons.

participants are refered to a specially designed website to encourage participation

Eligibility criteria:
inclusion criteria: * currently walking or running for exercise prior participation in the national runners' or walkers' health studies exclusion criteria: * under 18 years old no internet access

Keywords: exercise physical activity walking running
30 week study of the combination of abt-335 and rosuvastatin compared to rosuvastatin monotherapy for subjects with dyslipidemia and stage 3 chronic kidney disease

Conditions: Dyslipidemia; Kidney Disease

Summary: the objective of this study is to evaluate the safety and efficacy of the combination of abt-335 plus rosuvastatin in dyslipidemic subjects with chronic kidney disease (ckd) stage 3.


Eligibility criteria:
inclusion criteria * dyslipidemic participants with chronic kidney disease stage 3 * for entry into the treatment phase (visit 3), the participant satisfied the following laboratory criteria (measured at the screening visit\[s\]): * estimated glomerular filtration rate between 30 and 59 ml/min/1.73 m2 (chronic kidney disease stage 3) by simplified 4 variable modification of diet in renal disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay). * fasting lipid results following greater than or equal to 12-hour fasting period: * triglycerides level greater than or equal to 150 mg/dl, * high-density lipoprotein cholesterol less than 40 mg/dl for males and less than 50 mg/dl for females, and * low-density lipoprotein cholesterol greater than or equal to 130 mg/dl exclusion criteria * participants with certain chronic or unstable medical conditions. * participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications. * pregnant or lactating women, or women intending to become pregnant. * participants with diabetes mellitus that is poorly controlled. * participants of asian ancestry (having filipino, chinese, japanese, korean, vietnamese, or asian-indian origin).

Keywords: dyslipidemia kidney disease